Customed 712057462215
Customed 712057462215 (9002215) is a Class II device made by Customed, Inc., cleared under FDA 510(k) K081633 on 11 Aug 2008 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI M20890022151), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM20890022151 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081633 | Date11 Aug 2008 | StatusActive |
Official records
- FDA 510(k) database K081633
Across registries
- FDA 510(k) K081633 decided 11 Aug 2008 Active
- FDA GUDID UDI-DI M20890022151 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K081633
- Listed FDA GUDID M20890022151
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Customed
- Generic name
- Surgical/medical face mask, single-use
- Model / Ref / Catalog
- 712057462215, 9002215
- Primary DI / UDI-DI
- M20890022151
- 510(k) Number
- FDA product code
- FXX
- GMDN term
- Surgical/medical face mask, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code FXX (Mask, Surgical).
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- Medical Face Mask by Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.